FDA Grants Breakthrough Therapy and Fast Track Status to 68Ga-NYM096 in ccRCC

The FDA has granted both breakthrough therapy and fast track designations to 68Ga-NYM096, an investigational gallium-68–labeled PET imaging agent targeting carbonic anhydrase IX (CAIX), for the characterization of clear cell renal cell carcinoma (ccRCC).¹

The designation marks the first time a China-originated radiopharmaceutical has received FDA breakthrough therapy designation, according to a news release from Norroy Bioscience. 68Ga-NYM096 is designed to noninvasively characterize indeterminate renal masses identified on CT or MRI and to differentiate ccRCC from non-ccRCC lesions.

Findings from a preliminary stuyd presented during the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting showed that among 23 patients with an indeterminate primary renal mass, 68Ga-NYM096 PET yielded a sensitivity of 92.9%, specificity of 100%, and accuracy of 95.7% against histopathology as the reference standard (n = 14 ccRCC, n = 9 non-ccRCC; PET positive, n = 13, with 0 false positives; PET negative, n = 10, with 1 false negative).² The single patient with an ex-renal lesion suspected of ccRCC was confirmed as a true positive by histopathologic examination.² Among PET-positive lesions, mean SUVmax was 53.8 (SD, 32.3; range, 4.9-111.8), significantly higher than the mean SUVmax of 6.1 (SD, 2.9) observed on same-patient 18F-FDG PET (P < .001).

"We have seen promising clinical data from the ongoing development of ⁶⁸Ga-NYM096, supporting its potential to advance the diagnosis and management of patients with ccRCC,” Peng Fang, the founder and chief executive officer of Norroy Bioscience, stated in the news release.¹ “Additional clinical data of ⁶⁸Ga-NYM096 will be presented at the 2026 EANM Annual Congress. We plan to initiate phase I clinical trials evaluating ⁶⁸Ga-NYM096 in both China and the United States, and will continue to work closely with the FDA to advance its clinical development. We believe this innovative imaging agent has the potential to reshape the diagnosis and management of ccRCC and ultimately benefit more patients worldwide."

How was the preliminary study designed?

The open-label, single-center study enrolled 24 patients with a mean age of 56.7 years (SD, 14.4) with either an initially indeterminate renal mass scheduled for surgery (group 1; n = 23) or an ex-renal lesion suspected of ccRCC scheduled for biopsy (group 2; n = 1).²

Patients received an intravenous injection of 2 to 5 mCi of 68Ga-NYM096 followed by whole-body PET/CT approximately 60 minutes later; a subset also underwent 18F-FDG PET/CT within 1 week of the 68Ga-NYM096 scan for comparison. Histopathology from surgical resection or biopsy served as the reference standard for diagnostic accuracy.

References

1. NORROY BIOSCIENCE Granted FDA Breakthrough Therapy and Fast Track Designations for Kidney Cancer Imaging Product. News release. Norroy Bioscience Co., Ltd. August 19, 2026. Accessed August 20, 2026. https://www.prnewswire.com/news-releases/norroy-bioscience-granted-fda-breakthrough-therapy-and-fast-track-designations-for-kidney-cancer-imaging-product-302854931.html
2. Xue Y, Yu W, Wu T, et al. [68Ga]Ga-NYM096 PET/CT in patients with indeterminate renal mass and suspected metastatic clear cell renal cell carcinoma: a preliminary study. J Clin Oncol. 2026;44(suppl 16):4537. doi:10.1200/JCO.2026.44.16_suppl.4537